Designing an Implementable Clinical Prediction Model for Near-Term Mortality and Long-Term Survival in Patients on Maintenance Hemodialysis.

RATIONALE & OBJECTIVE: The life expectancy of patients treated with maintenance hemodialysis (MHD) is heterogeneous. Knowledge of life-expectancy may focus care decisions on near-term versus long-term goals. The current tools are limited and focus on near-term mortality. Here, we develop and assess potential utility for predicting near-term mortality and long-term survival on MHD. STUDY DESIGN: Predictive modeling study. SETTING & PARTICIPANTS: 42,351 patients contributing 997,381 patient months over 11 years, abstracted from the electronic health record (EHR) system of midsize, nonprofit dialysis providers. NEW PREDICTORS & ESTABLISHED PREDICTORS: Demographics, laboratory results, vital signs, and service utilization data available within dialysis EHR. OUTCOME: For each patient month, we ascertained death within the next 6 months (ie, near-term mortality) and survival over more than 5 years during receipt of MHD or after kidney transplantation (ie, long-term survival). ANALYTICAL APPROACH: We used least absolute shrinkage and selection operator logistic regression and gradient-boosting machines to predict each outcome. We compared these to time-to-event models spanning both time horizons. We explored the performance of decision rules at different cut points. RESULTS: All models achieved an area under the receiver operator characteristic curve of≥0.80 and optimal calibration metrics in the test set. The long-term survival models had significantly better performance than the near-term mortality models. The time-to-event models performed similarly to binary models. Applying different cut points spanning from the 1st to 90th percentile of the predictions, a positive predictive value (PPV) of 54% could be achieved for near-term mortality, but with poor sensitivity of 6%. A PPV of 71% could be achieved for long-term survival with a sensitivity of 67%. LIMITATIONS: The retrospective models would need to be prospectively validated before they could be appropriately used as clinical decision aids. CONCLUSIONS: A model built with readily available clinical variables to support easy implementation can predict clinically important life expectancy thresholds and shows promise as a clinical decision support tool for patients on MHD. Predicting long-term survival has better decision rule performance than predicting near-term mortality. PLAIN-LANGUAGE SUMMARY: Clinical prediction models (CPMs) are not widely used for patients undergoing maintenance hemodialysis (MHD). Although a variety of CPMs have been reported in the literature, many of these were not well-designed to be easily implementable. We consider the performance of an implementable CPM for both near-term mortality and long-term survival for patients undergoing MHD. Both near-term and long-term models have similar predictive performance, but the long-term models have greater clinical utility. We further consider how the differential performance of predicting over different time horizons may be used to impact clinical decision making. Although predictive modeling is not regularly used for MHD patients, such tools may help promote individualized care planning and foster shared decision making.

Comparative Effectiveness of Alternative Treatment Approaches to Secondary Hyperparathyroidism in Patients Receiving Maintenance Hemodialysis: An Observational Trial Emulation.

RATIONALE & OBJECTIVE: Optimal approaches to treat secondary hyperparathyroidism (SHPT) in patients on maintenance hemodialysis (HD) have yet to be established in randomized controlled trials (RCTs). STUDY DESIGN: Two observational clinical trial emulations. SETTING & PARTICIPANTS: Both emulations included adults receiving in-center HD from a national dialysis organization. The patients who had SHPT in the period between 2009 and 2014, were insured for≥180 days by Medicare as primary payer, and did not have contraindications or poor health status limiting theoretical trial participation. EXPOSURE: The parathyroid hormone (PTH) Target Trial emulation included patients with new-onset SHPT (first PTH 300-600pg/mL), with 2 arms defined as up-titration of either vitamin D sterols or cinacalcet within 30 days (lower target) or no up-titration (higher target). The Agent Trial emulation included patients with a PTH≥300 pg/mL while on≥6µg weekly of vitamin D sterol (paricalcitol equivalent dose) and no prior history of cinacalcet. The 2 arms were defined by the first dose or agent change within 30 days (vitamin D-favoring [vitamin-D was up-titrated] vs cinacalcet-favoring [cinacalcet was added] vs nondefined [neither applies]). Multiple trials per patient were allowed in trial 2. OUTCOME: The primary outcome was all-cause death over 24 months; secondary outcomes included cardiovascular (CV) hospitalization or the composite of CV hospitalization or death. ANALYTICAL APPROACH: Pooled logistic regression. RESULTS: There were 1,152 patients in the PTH Target Trial (635 lower target and 517 higher target). There were 2,726 unique patients with 6,727 patient trials in the Agent Trial (6,268 vitamin D-favoring trials and 459 cinacalcet-favoring trials). The lower PTH target approach was associated with reduced adjusted hazard of death (HR, 0.71 [95% CI, 0.52-0.93]), CV hospitalization (HR, 0.78 [95% CI, 0.63-0.98]), and their composite (HR, 0.74 [95% CI, 0.61-0.89]). The cinacalcet-favoring approach demonstrated lower adjusted hazard of death compared to the vitamin D-favoring approach (HR, 0.79 [95% CI, 0.62-0.99]), but not of CV hospitalization or the composite outcome. LIMITATIONS: Potential for residual confounding; low use of cinacalcet with low power. CONCLUSIONS: SHPT management that is focused on lower PTH targets may lower mortality and CV disease in patients receiving HD. These findings should be confirmed in a pragmatic randomized trial. PLAIN-LANGUAGE SUMMARY: Optimal approaches to treat secondary hyperparathyroidism (SHPT) have not been established in randomized controlled trials. Data from a national dialysis organization was used to identify patients with SHPT in whom escalated treatment may be indicated. The approach to treatment was defined based on observed upward titration of SHPT-controlling medications: earlier titration (lower target) versus delayed titration (higher target); and the choice of medication (cinacalcet vs vitamin D sterols). In the first trial emulation, we estimated a 29% lower rate of death and 26% lower rate of cardiovascular disease or death for patients managed with a lower versus higher target approach. Cinacalcet versus vitamin D-favoring approaches were not consistently associated with outcomes in the second trial emulation. This observational study suggests the need for additional clinical trials of SHPT treatment intensity.

Association of Age and Gender With Concerns About Live Donor Kidney Transplantation Among Black Individuals.

Black individuals are less likely to receive live donor kidney transplantation (LDKT) compared to others. This may be partly related to their concerns about LDKT, which can vary based on age and gender. We conducted a cross-sectional, secondary analysis of the baseline enrollment data from the Talking about Living Kidney Donation Support trial, which studied the effectiveness of social workers and financial interventions on activation towards LDKT among 300 Black individuals from a deceased donor waiting list. We assessed concerns regarding the LDKT process, including their potential need for postoperative social support, future reproductive potential, recipient and donor money matters, recipient and donor safety, and interpersonal concerns. Answers ranged from 0 ("not at all concerned") to 10 ("extremely concerned"). We described and compared participants' concerns both overall and stratified by age (≥45 years old vs <45 years old) and self-reported gender ("male" versus "female"). The participants' top concerns were donor safety (median [IQR] score 10 [5-10]), recipient safety (5 [0-10]), money matters (5 [0-9]), and guilt/indebtedness (5 [0-9]). Younger females had statistically significantly higher odds of being concerned about future reproductive potential (odds ratio [OR] 3.77, 95% CI 2.77, 4.77), and older males had statistically higher mean concern about postoperative social support (OR 1.79, 95% CI 0.19, 3.38). Interventions to improve rates of LDKT among Black individuals should include education and counseling about the safety of LDKT for both recipients and donors, reproductive counseling for female LDKT candidates of childbearing age, and addressing older males' needs for increased social support.

Continuous glucose monitors and virtual care in high-risk, racial and ethnic minority populations: Toward promoting health equity.

Continuous glucose monitors (CGMs) have become an important tool to aid self-management of blood glucose for many patients with diabetes in the U.S., and the benefits of CGM use are well-documented. However, disparities in CGM use exist, with lower use in certain marginalized racial and ethnic groups. CGM may be an important and underutilized tool to help reduce inequities. Evidence supporting the use of CGMs as a part of virtual care is discussed, with an emphasis on designing virtual diabetes care programs to promote health equity. Recommendations for clinical practice and research are presented. In clinical practice, CGM should be an option for all people with diabetes who qualify based on clinical practice guidelines, regardless of race, ethnicity, or other individual characteristics. Future research should characterize the use of, benefit from, and preferences for CGM among individuals from racial and ethnic groups to guide interventions at the health system, clinic, provider, and patient levels to promote equitable, evidence-based, and guideline-directed CGM use in marginalized racial and ethnic groups with diabetes.

Development of an Administrative Data-Based Frailty Index for Older Adults Receiving Dialysis.

Background: Frailty is present in ≥50% of older adults receiving dialysis. Our objective was to a develop an administrative data-based frailty index and assess the frailty index's predictive validity for mortality and future hospitalizations. Methods: We used United States Renal Data System data to establish two cohorts of adults aged ≥65 years, initiating dialysis in 2013 and in 2017. Using the 2013 cohort (development dataset), we applied the deficit accumulation index approach to develop a frailty index. Adjusting for age and sex, we assessed the extent to which the frailty index predicts the hazard of time until death and time until first hospitalization over 12 months. We assessed the Harrell's C-statistic of the frailty index, a comorbidity index, and jointly. The 2017 cohort was used as a validation dataset. Results: Using the 2013 cohort (n=20,974), we identified 53 deficits for the frailty index across seven domains: disabilities, diseases, equipment, procedures, signs, tests, and unclassified. Among those with ≥1 deficit, the mean (SD) frailty index was 0.30 (0.13), range 0.02-0.72. Over 12 months, 18% (n=3842) died, and 55% (n=11,493) experienced a hospitalization. Adjusted hazard ratios for each 0.1-point increase in frailty index in models of time to death and time to first hospitalization were 1.41 (95% confidence interval, 1.37 to 1.44) and 1.33 (95% confidence interval, 1.31 to 1.35), respectively. For mortality, C-statistics for frailty index, comorbidity index, and both indices were 0.65, 0.65, and 0.66, respectively. For hospitalization, C-statistics for frailty index, comorbidity index, and both indices were 0.61, 0.60, and 0.61, respectively. Data from the 2017 cohort were similar. Conclusions: We developed a novel frailty index for older adults receiving dialysis. Further studies are needed to improve on this frailty index and validate its use for clinical and research applications.

Decisional Conflict About Kidney Failure Treatment Modalities Among Adults With Advanced CKD.

Rationale & Objective: Choosing from multiple kidney failure treatment modalities can create decisional conflict, but little is known about this experience before decision implementation. We explored decisional conflict about treatment for kidney failure and its associated patient characteristics in the context of advanced chronic kidney disease (CKD). Study Design: Cross-sectional study. Setting & Participants: Adults (N = 427) who had advanced CKD, received nephrology care in Pennsylvania-based clinics, and had no history of dialysis or transplantation. Predictors: Participants' sociodemographic, physical health, nephrology care/knowledge, and psychosocial characteristics. Outcomes: Participants' results on the Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) screening test for decisional conflict (no decisional conflict vs decisional conflict). Analytical Approach: We used multivariable logistic regression to quantify associations between aforementioned participant characteristics and decisional conflict. We repeated analyses among a subgroup of participants at highest risk of kidney failure within 2 years. Results: Most (76%) participants reported treatment-related decisional conflict. Participant characteristics associated with lower odds of decisional conflict included complete satisfaction with patient-kidney team treatment discussions (OR, 0.16; 95% CI, 0.03-0.88; P = 0.04), attendance of treatment education classes (OR, 0.38; 95% CI, 0.16-0.90; P = 0.03), and greater treatment-related decision self-efficacy (OR, 0.97; 95% CI, 0.94-0.99; P < 0.01). Sensitivity analyses showed a similarly high prevalence of decisional conflict (73%) and again demonstrated associations of class attendance (OR, 0.26; 95% CI, 0.07-0.96; P = 0.04) and decision self-efficacy (OR, 0.95; 95% CI, 0.91-0.99; P = 0.03) with decisional conflict. Limitations: Single-health system study. Conclusions: Decisional conflict was highly prevalent regardless of CKD progression risk. Findings suggest efforts to reduce decisional conflict should focus on minimizing the mismatch between clinical practice guidelines and patient-reported engagement in treatment preparation, facilitating patient-kidney team treatment discussions, and developing treatment education programs and decision support interventions that incorporate decision self-efficacy-enhancing strategies.

Disparities in Discussions about Kidney Replacement Therapy in CKD Care.

Participants who identified as female and Black reported more thorough discussions of dialysis than transplant.Participants with low incomes and education reported more thorough discussions of dialysis than transplant.

The Impact of COVID-19 on Patient, Family Member, and Stakeholder Research Engagement: Insights from the PREPARE NOW Study.

BACKGROUND: Little is known about the impact of COVID-19 on patient, family member, and stakeholder patient-centered outcomes research engagement. OBJECTIVE: To answer the research questions: (1) What is the impact of COVID-19 on the lives of patients with kidney disease and their families? (2) What is the impact of COVID-19 on research engagement for patient and family member research team members who are themselves at very high risk for poor COVID-19 outcomes? and (3) How can we help patients, family members, and stakeholder team members engage in research during COVID-19? DESIGN: We conducted virtual semi-structured interviews with patient and family member co-investigators and kidney disease stakeholders from the PREPARE NOW study during November 2020. The interview guide included questions about participants' experiences with the impact of COVID-19 on research engagement. PARTICIPANTS: Seven patient and family member co-investigators and eight kidney disease stakeholders involved in a kidney disease patient-centered outcomes research project participated in the interviews, data analysis, and writing this manuscript. APPROACH: We used a content analysis approach and identified the main themes using an inductive process. KEY RESULTS: Respondents reported three main ways that COVID-19 has impacted their lives: emotional impact, changing behaviors, and changes in health care delivery. The majority of respondents reported no negative impact of COVID-19 on their ability to engage in this research project. Suggestions for patient-centered outcomes research during COVID-19 and other emergencies include virtual research activities; active engagement; and promoting trust, honesty, transparency, and authenticity. CONCLUSIONS: COVID-19 has had a significant negative impact on patient, family member, and stakeholder research team members; however, this has not resulted in less research engagement. TRIAL REGISTRATION: Clinicaltrials.gov NCT02722382.

Social Determinants of Health, Race, and Diabetes Population Health Improvement: Black/African Americans as a Population Exemplar.

PURPOSE OF REVIEW: To summarize evidence of impact of social determinants of health (SDOH) on diabetes risk, morbidity, and mortality and to illustrate this impact in a population context. RECENT FINDINGS: Key findings from the American Diabetes Association's scientific review of five SDOH domains (socioeconomic status, neighborhood and physical environment, food environment, health care, social context) are highlighted. Population-based data on Black/African American adults illustrate persisting diabetes disparities and inequities in the SDOH conditions in which this population is born, grows, lives, and ages, with historical contributors. SDOH recommendations from US national committees largely address a health sector response, including health professional education, SDOH measurement, and patient referral to services for social needs. Fewer recommendations address solutions for systemic racism and socioeconomic discrimination as root causes. SDOH are systemic, population-based, cyclical, and intergenerational, requiring extension beyond health care solutions to multi-sector and multi-policy approaches to achieve future population health improvement.

Preferences for and Experiences of Shared and Informed Decision Making Among Patients Choosing Kidney Replacement Therapies in Nephrology Care.

RATIONALE & OBJECTIVE: Chronic kidney disease (CKD) can progress rapidly, and patients are often unprepared to make kidney failure treatment decisions. We aimed to better understand patients' preferences for and experiences of shared and informed decision making (SDM) regarding kidney replacement therapy before kidney failure. STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: Adults receiving nephrology care at CKD clinics in rural Pennsylvania. PREDICTORS: Estimated glomerular filtration rate, 2-year risk for kidney failure, duration and frequency of nephrology care, and preference for SDM. OUTCOMES: Occurrence and extent of kidney replacement therapy discussions and participants' satisfaction with those discussions. ANALYTIC APPROACH: Multivariable logistic regression to quantify associations between participants' characteristics and whether they had discussions. RESULTS: The 447 study participants had a median age of 72 (IQR, 64-80) years and mean estimated glomerular filtration rate of 33 (SD, 12) mL/min/1.73 m2. Most (96%) were White, high school educated (67%), and retired (65%). Most (72%) participants preferred a shared approach to kidney treatment decision making, and only 35% discussed dialysis or transplantation with their kidney teams. Participants who had discussions (n = 158) were often completely satisfied (63%) but infrequently discussed potential treatment-related impacts on their lives. In multivariable analyses, those with a high risk for kidney failure within 2 years (OR, 3.24 [95% CI, 1.72-6.11]; P < 0.01), longer-term nephrology care (OR, 1.12 [95% CI, 1.05-1.20] per 1 additional year; P < 0.01), and more nephrology visits in the prior 2 years (OR, 1.34 [95% CI, 1.20-1.51] per 1 additional visit; P < 0.01) had higher odds of having discussed dialysis or transplantation. LIMITATIONS: Single health system study. CONCLUSIONS: Most patients preferred sharing CKD treatment decisions with their providers, but treatment discussions were infrequent and often did not address key treatment impacts. Longitudinal nephrology care and frequent visits may help ensure that patients have optimal SDM experiences.

Integrated Digital Health System Tools to Support Decision Making and Treatment Preparation in CKD: The PREPARE NOW Study.

RATIONALE & OBJECTIVE: Digital health system tools to support shared decision making and preparation for kidney replacement treatments for patients with chronic kidney disease (CKD) are needed. STUDY DESIGN: Descriptive study of the implementation of digital infrastructure to support a patient-centered health system intervention. SETTING & PARTICIPANTS: 4 CKD clinics within a large integrated health system. EXPOSURE: We developed an integrated suite of digital engagement tools to support patients' shared decision making and preparation for kidney failure treatments. Tools included an automated CKD patient registry and risk prediction algorithm within the electronic health record (EHR) to identify and prioritize patients in need of nurse case management to facilitate shared decision making and preparation for kidney replacement treatments, an electronic patient-facing values clarification tool, a tracking application to document patients' preparation for treatments, and an EHR work flow to broadcast patients' treatment preferences to all health care providers. OUTCOMES: Uptake and acceptability. ANALYTIC APPROACH: Mixed methods. RESULTS: From July 1, 2017, through June 30, 2018, the CKD registry identified 1,032 patients in 4 nephrology clinics, of whom 243 (24%) were identified as high risk for progressing to kidney failure within 2 years. Kidney Transitions Specialists enrolled 117 (48%) high-risk patients by the end of year 1. The values tool was completed by 30/33 (91%) patients who attended kidney modality education. Nurse case managers used the tracking application for 100% of patients to document 287 planning steps for kidney replacement therapy. Most (87%) high-risk patients had their preferred kidney replacement modality documented and displayed in the EHR. Nurse case managers reported that the tools facilitated their identification of patients needing support and their navigation activities. LIMITATIONS: Single institution, short duration. CONCLUSIONS: Digital health system tools facilitated rapid identification of patients needing shared and informed decision making and their preparation for kidney replacement treatments. FUNDING: This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Project Program Award (IHS-1409-20967). TRIAL REGISTRATION: ClinicalTrials.gov NCT02722382.

Risks associated with continuation of potentially inappropriate antihypertensive medications in older adults receiving hemodialysis.

BACKGROUND AND OBJECTIVES: After dialysis initiation, older adults may experience orthostatic or post-dialysis hypotension. Some orthostasis-causing antihypertensives (i.e., central alpha agonists and alpha blockers), are considered potentially inappropriate medications (PIMs) for older adults because they carry more risk than benefit. We sought to (1) describe antihypertensive PIM prescribing patterns before and after dialysis initiation and (2) ascertain the potential risk of adverse outcomes when these medications are continued after dialysis initiation. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Using United States Renal Data System data, we evaluated monthly prevalence of antihypertensive PIM claims in the period before and after dialysis initiation among older adults aged ≥66 years initiating in-center hemodialysis in the US between 2013 and 2014. Patients with an antihypertensive PIM prescription at hemodialysis initiation and who survived for 120 days were classified as 'continuers' or 'discontinuers' based on presence or absence of a refill within the 120 days after initiation. We compared rates of hospitalization and risk of death across these groups from day 121 through 24 months after dialysis initiation. RESULTS: Our study included 30,760 total patients, of whom 5981 (19%) patients had an antihypertensive PIM claim at dialysis initiation and survived ≥120 days. Most [65% (n = 3920)] were continuers. Those who continued (versus discontinued) were more likely to be black race (26% versus 21%), have dual Medicare-Medicaid coverage (31% versus 27%), have more medications on average (12 versus 9) and have no functional limitations (84% versus 80%). Continuers experienced fewer all-cause hospitalizations and deaths, but neither were statistically significant after adjustment (Hospitalization: RR 0.93, 95% CI 0.86, 1.00; Death: HR 0.89, 95% CI: 0.78-1.02). CONCLUSIONS: Nearly one in five older adults had an antihypertensive PIM at dialysis initiation. Among those who survived ≥120 days, continuation of an antihypertensive PIM was not associated with increased risk of all-cause hospitalization or mortality.

The Relationship Between Neighborhood Deprivation and Perceived Changes for Pain-Related Experiences Among US Patients with Chronic Low Back Pain During the COVID-19 Pandemic.

OBJECTIVE: Disruptions caused by the COVID-19 pandemic could disproportionately affect the health of vulnerable populations, including patients experiencing persistent health conditions (i.e., chronic pain), along with populations living within deprived, lower socioeconomic areas. The current cross-sectional study characterized relationships between neighborhood deprivation and perceived changes in pain-related experiences during the COVID-19 pandemic (early-September to mid-October 2020) for adult patients (N = 97) with nonspecific chronic low back pain. METHODS: We collected self-report perceived experiences from participants enrolled in an ongoing pragmatic randomized trial across medical centers within the Salt Lake City, Utah and Baltimore, Maryland metropolitans. The Area Deprivation Index (composite of 17 US Census deprivation metrics) reflected neighborhood deprivation based on participants' zip codes. RESULTS: Although those living in the neighborhoods with greater deprivation endorsed significantly poorer physical (pain severity, pain interference, physical functioning), mental (depression, anxiety), and social health during the pandemic, there were no significant differences for perceived changes in pain-related experiences (pain severity, pain interference, sleep quality) between levels of neighborhood deprivation since the onset of the pandemic. However, those in neighborhoods with greater deprivation endorsed disproportionately worse perceived changes in pain coping, social support, and mood since the pandemic. CONCLUSIONS: The current findings offer evidence that changes in pain coping during the pandemic may be disproportionately worse for those living in deprived areas. Considering poorer pain coping may contribute to long-term consequences, the current findings suggest the need for further attention and intervention to reduce the negative effect of the pandemic for such vulnerable populations.

Patients' and family members' perspectives on arrhythmias and sudden death in dialysis: the HeartLink focus groups pilot study.

BACKGROUND: Patients receiving dialysis face a high risk of cardiovascular disease, arrhythmia and sudden cardiac death. Few patients, however, are aware of this risk. Implantable cardiac monitors are currently available for clinical use and can continuously monitor cardiac rhythms without the need for transvenous leads. Our goal was to gauge patients' and family members' perceptions of these risks and to identify their concerns about cardiac monitors. METHODS: Two 90-minute focus groups were conducted: one with patients receiving in-center hemodialysis and one with their family members. Trained moderators assessed: (1) knowledge of cardiovascular disease; (2) cardiovascular disease risk in dialysis; (3) risk of death due to cardiovascular disease; (4) best ways to convey this risk to patients/families; and (5) concerns about cardiac monitors. The sessions were audiotaped, transcribed, and independently analyzed by two reviewers to identify core themes. Emblematic quotations were chosen to illustrate the final themes. RESULTS: Nine adult patients and three family members participated. Patients felt education was inadequate and had little knowledge of arrhythmias. Patients'/families' concerns regarding cardiac monitors were related to adverse effects, the notification process, and cosmetic effects. Patients/families felt that nephrologists, not dialysis staff, would be the best source for education. CONCLUSIONS: The preliminary data from this small study population suggest that patients/families are not well aware of the high risk of arrhythmia and sudden cardiac death in dialysis. Further investigation is required to gauge this awareness among patients/families and to assess their impressions of implantable cardiac monitors for arrhythmia detection and management.

Stratified care to prevent chronic low back pain in high-risk patients: The TARGET trial. A multi-site pragmatic cluster randomized trial.

BACKGROUND: Many patients with acute low back pain (LBP) first seek care from primary care physicians. Evidence is lacking for interventions to prevent transition to chronic LBP in this setting. We aimed to test if implementation of a risk-stratified approach to care would result in lower rates of chronic LBP and improved self-reported disability. METHODS: We conducted a pragmatic, cluster randomized trial using 77 primary care clinics in four health care systems across the United States. Practices were randomly assigned to a stratified approach to care (intervention) or usual care (control). Using the STarTBack screening tool, adults with acute LBP were screened low, medium, and high-risk. Patients screened as high-risk were eligible. The intervention included electronic best practice alerts triggering referrals for psychologically informed physical therapy (PIPT). PIPT education was targeted to community clinics geographically close to intervention primary care clinics. Primary outcomes were transition to chronic LBP and self-reported disability at six months. Trial Registry: ClinicalTrials.gov NCT02647658. FINDINGS: Between May 2016 and June 2018, 1207 patients from 38 intervention and 1093 from 37 control practices were followed. In the intervention arm, around 50% of patients were referred for physical therapy (36% for PIPT) compared to 30% in the control. At 6 months, 47% of patients reported transition to chronic LBP in the intervention arm (38 practices, n = 658) versus 51% of patients in the control arm (35 practices, n = 635; OR=0.83 95% CI 0.64, 1.09; p = 0.18). No differences in disability were detected (difference -2·1, 95% CI -4.9-0.6; p = 0.12). Opioids and imaging were prescribed in 22%-25% and 23%-26% of initial visits, for intervention and control, respectively. Twelve-month LBP utilization was similar in the two groups. INTERPRETATION: There were no differences detected in transition to chronic LBP among patients presenting with acute LBP using a stratified approach to care. Opioid and imaging prescribing rates were non-concordant with clinical guidelines. FUNDING: Patient-Centered Outcomes Research Institute (PCORI) contract # PCS-1402-10867.

Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care.

Importance: Acute low back pain (LBP) is highly prevalent, with a presumed favorable prognosis; however, once chronic, LBP becomes a disabling and expensive condition. Acute to chronic LBP transition rates vary widely owing to absence of standardized operational definitions, and it is unknown whether a standardized prognostic tool (ie, Subgroups for Targeted Treatment Back tool [SBT]) can estimate this transition or whether early non-guideline concordant treatment is associated with the transition to chronic LBP. Objective: To assess the associations between the transition from acute to chronic LBP with SBT risk strata; demographic, clinical, and practice characteristics; and guideline nonconcordant processes of care. Design, Setting, and Participants: This inception cohort study was conducted alongside a multisite, pragmatic cluster randomized trial. Adult patients with acute LBP stratified by SBT risk were enrolled in 77 primary care practices in 4 regions across the United States between May 2016 and June 2018 and followed up for 6 months, with final follow-up completed by March 2019. Data analysis was conducted from January to March 2020. Exposures: SBT risk strata and early LBP guideline nonconcordant processes of care (eg, receipt of opioids, imaging, and subspecialty referral). Main Outcomes and Measures: Transition from acute to chronic LBP at 6 months using the National Institutes of Health Task Force on Research Standards consensus definition of chronic LBP. Patient demographic characteristics, clinical factors, and LBP process of care were obtained via electronic medical records. Results: Overall, 5233 patients with acute LBP (3029 [58%] women; 4353 [83%] White individuals; mean [SD] age 50.6 [16.9] years; 1788 [34%] low risk; 2152 [41%] medium risk; and 1293 [25%] high risk) were included. Overall transition rate to chronic LBP at six months was 32% (1666 patients). In a multivariable model, SBT risk stratum was positively associated with transition to chronic LBP (eg, high-risk vs low-risk groups: adjusted odds ratio [aOR], 2.45; 95% CI, 2.00-2.98; P < .001). Patient and clinical characteristics associated with transition to chronic LBP included obesity (aOR, 1.52; 95% CI, 1.28-1.80; P < .001); smoking (aOR, 1.56; 95% CI, 1.29-1.89; P < .001); severe and very severe baseline disability (aOR, 1.82; 95% CI, 1.48-2.24; P < .001 and aOR, 2.08; 95% CI, 1.60-2.68; P < .001, respectively) and diagnosed depression/anxiety (aOR, 1.66; 95% CI, 1.28-2.15; P < .001). After controlling for all other variables, patients exposed to 1, 2, or 3 nonconcordant processes of care within the first 21 days were 1.39 (95% CI, 1.21-2.32), 1.88 (95% CI, 1.53-2.32), and 2.16 (95% CI, 1.10-4.25) times more likely to develop chronic LBP compared with those with no exposure (P < .001). Conclusions and Relevance: In this cohort study, the transition rate to chronic LBP was substantial and increased correspondingly with SBT stratum and early exposure to guideline nonconcordant care.

Impact of pre-dialysis nephrology care engagement and decision-making on provider and patient action toward permanent vascular access.

BACKGROUND: While catheters are often thought the result of emergency hemodialysis (HD) initiation among patients with little or no pre-dialysis nephrology care, the role of patient level of engagement in care and modality decision-making have not been fully explored. METHODS: This is a retrospective medical record review of adults (age 18-89 years) who received care in academically affiliated private practice, public hospital, or Veterans Administration settings prior to initiating HD with a catheter between 10/1/2011 and 9/30/2012. Primary predictors were level of patient engagement in nephrology care within 6 months of HD initiation and timing of modality decision-making. Primary outcomes were provider action (referral) and any patient action (evaluation by a vascular surgeon, vein mapping or vascular surgery) toward [arteriovenous fistula or graft, (AVF/AVG)] creation. RESULTS: Among 92 incident HD patients, 66% (n = 61) initiated HD via catheter, of whom 34% (n = 21) had ideal engagement in care but 42% (n = 25) had no documented decision. Providers referred 48% (n = 29) of patients for AVF/AVG, of whom 72% (n = 21) took any action. Ideal engagement in care predicted provider action (adjusted OR 13.7 [95% CI 1.08, 175.1], p = 0.04), but no level of engagement in care predicted patient action (p > 0.3). Compared to patients with no documented decision, those with documented decisions within 3, 3-12, or more than 12 months before initiating dialysis were more likely to have provider action toward AVF/AVG (adjusted OR [95% CI]: 9.0 [1.4,55.6], p = 0.2, 37.6 [3.3423.4] p = 0.003, and 4.8 [0.8, 30.6], p = 0.1, respectively); and patient action (adjusted OR [95% CI]: 18.7 [2.3, 149.0], p = 0.006, 20.4 [2.6, 160.0], p = 0.004, and 6.2 [0.9, 44.0], p = 0.07, respectively). CONCLUSIONS: Timing of patient modality decision-making, but not level of engagement in pre-dialysis nephrology care, was predictive of patient and provider action toward AVF/AVG Interventions addressing patients' psychological preparation for dialysis are needed.

African Americans' discussions about living-donor kidney transplants with family or friends: Who, what, and why not?

BACKGROUND: Although discussions with family or friends can improve access to living-donor kidney transplantation (LDKT), they remain an understudied step in the LDKT process. METHODS: Among 300 African American transplant candidates, we examined how sociodemographic, clinical, LDKT-related, and psychosocial characteristics related to the occurrence of LDKT discussions with family or friends. We also analyzed the relation between discussion occurrence and donor activation on transplant candidates' behalves (at least one donor inquiry or completed donor evaluation in the medical record). We assessed associations of discussion characteristics (context, content, and perceptions) with donor activation among discussants, and we identified discussion barriers among non-discussants. RESULTS: Most candidates (90%) had discussed LDKT. Only family functioning was statistically significantly associated with discussion occurrence. Specifically, family dysfunction was associated with 62% lower odds of discussion than family function. Family functioning, discussion occurrence, and different discussion characteristics were statistically significantly related to donor activation. The most prevalent discussion barrier was never having thought about discussing LDKT. CONCLUSIONS: Family functioning affected the likelihood of discussing LDKT, and family functioning, discussion occurrence, and discussion characteristics were associated with donor activation. Advancing understanding of how family functioning and LDKT discussions affect progression to LDKT may benefit interventions to increase LDKT.

Hypoglycemia Communication in Primary Care Visits for Patients with Diabetes.

BACKGROUND: Hypoglycemia is a common and serious adverse effect of diabetes treatment, especially for patients using insulin or insulin secretagogues. Guidelines recommend that these patients be assessed for interval hypoglycemic events at each clinical encounter and be provided anticipatory guidance for hypoglycemia prevention. OBJECTIVE: To determine the frequency and content of hypoglycemia communication in primary care visits. DESIGN: Qualitative study PARTICIPANTS: We examined 83 primary care visits from one urban health practice representing 8 clinicians and 33 patients using insulin or insulin secretagogues. APPROACH: Using a directed content analysis approach, we analyzed audio-recorded primary care visits collected as part of the Achieving Blood Pressure Control Together study, a randomized trial of behavioral interventions for hypertension. The coding framework included communication about interval hypoglycemia, defined as discussion of hypoglycemic events or symptoms; the components of hypoglycemia anticipatory guidance in diabetes guidelines; and hypoglycemia unawareness. Hypoglycemia documentation in visit notes was compared to visit transcripts. KEY RESULTS: Communication about interval hypoglycemia occurred in 24% of visits, and hypoglycemic events were reported in 16%. Despite patients voicing fear of hypoglycemia, clinicians rarely assessed hypoglycemia frequency, severity, or its impact on quality of life. Hypoglycemia anticipatory guidance was provided in 21% of visits which focused on diet and behavior change; clinicians rarely counseled on hypoglycemia treatment or avoidance of driving. Limited discussions of hypoglycemia unawareness occurred in 8% of visits. Documentation in visit notes had low sensitivity but high specificity for ascertaining interval hypoglycemia communication or hypoglycemic events, compared to visit transcripts. CONCLUSIONS: In this high hypoglycemia risk population, communication about interval hypoglycemia and counseling for hypoglycemia prevention occurred in a minority of visits. There is a need to support clinicians to more regularly assess their patients' hypoglycemia burden and enhance counseling practices in order to optimize hypoglycemia prevention in primary care.

Transplant social worker and donor financial assistance to increase living donor kidney transplants among African Americans: The TALKS Study, a randomized comparative effectiveness trial.

Lack of donors hinders living donor kidney transplantation (LDKT) for African Americans. We studied the effectiveness of a transplant social worker intervention (TALK SWI) alone or paired with living donor financial assistance to activate African Americans' potential living kidney donors. African Americans (N = 300) on the transplant waiting list were randomly assigned to usual care; TALK SWI; or TALK SWI plus Living Donor Financial Assistance. We quantified differences in live kidney donor activation (composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) after 12 months. Participants' mean age was 52 years, 56% were male, and 43% had annual household income less than $40,000. Most previously pursued LDKT. Participants were highly satisfied with TALK social workers, but they rarely utilized Financial Assistance. After 12 months, few (n = 39, 13%) participants had a new donor activation event (35 [12%] new donor inquiries; 17 [6%] new donor evaluations; 4 [1%] LDKT). There were no group differences in donor activation events (subdistribution hazard ratio [95% CI]: 1.09 [0.51-2.30] for TALK SWI and 0.92 [0.42-2.02] for TALK SWI plus Financial Assistance compared to Usual Care, p = 91). Alternative interventions to increase LDKT for African Americans on the waiting list may be needed. Trial registration: ClinicalTrials.gov (NCT02369354).